Biotronik said today it won FDA premarket approval for its quadripolar Itrevia HF-T cardiac resynchronization defibrillator and launched the device in the U.S. market.
The device includes a closed loop stimulation algorithm, capable of adapting heart rate in response to physiological demands independent of movement or respiration, Biotronik said.
“The FDA has approved CLS as the only system to respond to acute mental stress and now this unique technology is available for more patients who can benefit from the expanded programming options of a quadripolar device. CLS and Biotronik home monitoring are core technologies in our Biotronik pacemakers and ICDs because we know, and have clinical evidence, that these technologies can improve the quality of patients’ lives,” president Marlou Janssen said in prepared remarks.
The Itrevia is approved for use with IS4 compatible left ventricular leads, the German medical device giant said. The 1st patients have already been implanted with the device, the company added.
“This device meets standards of other devices in the market and then adds CLS. My patients with heart failure have greater risk of falling due to the incidence of orthostatic hypotension and it is beneficial to have the option of using CLS to treat them,” Dr. Alexander Mazur of the University of Iowa said in a press release.
Earlier this month, Biotronik released an MRI-safe version of the Itrevia in Japan, part of a Japanese rollout of new devices for 2015. Biotronik said that Japan is the world’s largest MRI market with 47 MRI scanners per 1 million people, more than any other country.
In May, Biotronik launched its CardioMessenger Smart 3G and Iforia 7 DR-T and VR-T DF4 MRI-safe implantable cardiac defibrillators in Japan. The devices are designed to communicate to allow physicians to manage data from patients’ implantable devices, transmitted via the company’s home monitoring system.